Sarcopenia
Conditions
Interventions
Low-dose group:ZS112 injection
Dose-extension group:ZS112 injection
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 60 years = Age =80 years at the time of signing the informed consent, female; 2. Participants need to meet the definition of sarcopenia that published by Asian Working Group for Sarcopenia (AWGS2) ; 3. The participants voluntarily participate and are fully informed, fully understand the study and are able to comply with the requirements of the research protocol.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to any component of the study drug or a condition that can not use; 2. BMI less than 15.0 or greater than 32.0 kg/m2; 3. AAV capsid neutralizing antibody positive; 4. Any conditions that affect the assessment of the subject's physical function; 5. Have a history of malignant tumors or currently have any malignant tumors; 6. Have an active autoimmune disease that requires immunosuppressive therapy or glucocorticoid therapy; 7. Severe heart disease, including angina pectoris, myocardial infarction, heart failure, clinically significant congenital heart disease, heart valve disease, arrhythmia, etc.; 8. Chronic kidney disease [CKD] stage =4; 9. Very severe chronic obstructive pulmonary disease (COPD); 10. A history of potentially serious liver disease or liver disease; 11. Diabetic subjects with poor control after drug treatment; 12. Uncontrolled high blood pressure; 13. Acute/chronic infectious diseases or other chronic diseases that the investigator judged would increase the risk of participating in the trial; 14. Hemoglobin 2× upper normal value (ULN), total bilirubin > 1.5× upper normal value (ULN), alkaline phosphatase > 2× upper normal value (ULN); 15. Patients with planned operation during the observation period; 16. Epilepsy, history of mental illness, obvious mental disorder, or other causes of incapacity or cognitive disability; 17. Investigators believe that subjects have poor compliance or are expected to be less likely to complete follow-up; 18. There are clinically significant diseases or other reasons that the researcher and/or collaborators consider unsuitable to participate in this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Vital signs;Physical examination;Laboratory examination;AAV neutralizing antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical function evaluation;Grip strength test;Vector shedding; | — |
Countries
CHINA
Contacts
Public ContactJirong Yue
West China Hospital, Sichuan University
Outcome results
None listed